Ignite Creation Date:
2024-05-06 @ 1:14 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03972046
Status:
WITHDRAWN
Last Update Posted:
2020-10-19
First Post:
2019-05-31
Brief Title:
Neoadjuvant Use of Talimogene Laherparepvec and BRAFMEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma
Sponsor:
TriHealth Inc
Organization:
TriHealth Inc
Study Overview
Official Title:
Neoadjuvant Use of Talimogene Laherparepvec and BRAFMEK Inhibitor for Advanced Nodal BRAF Mutant Melanoma A Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal investigator leaving study site no replacement PI will be sought
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will investigate whether the use of talimogene laherparepvec T-VEC in combination with BRAFMEK inhibitor will result in durable regional and distant recurrence free survival in the neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma
Detailed Description:
This is a prospective non-randomized open-label single-center interventional study looking at the response rate when using talimogene laherparepvec T-VEC in combination with BRAFMEK inhibitor in neoadjuvant setting for treatment of advanced nodal BRAF mutant melanoma For this pilot study a sample size of 20 participants over 18 years of age will be included
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20177504 | OTHER_GRANT | Amgen Inc | None |